Label: MAMISAN PAIN RELIEVING CREAM LIDOCAINE PLUS MENTHOL- lidocaine hydrochloride, menthol cream

  • NDC Code(s): 72816-001-01
  • Packager: PLANTIMEX DISTRIBUTORS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Lidocaine HCl 4%

    Menthol 1%

    Purpose

    Topical anesthetic

    Topical analgesic

  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings on this label
    • rare cases of serious burns have been reported with products of this type
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use with a medicated patch
    • avoid contact with the eyes and mucous membranes.
    • a transient burning sensation may occur upon application but generally disappears in several days.

    Stop use and ask doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    If pregnant or breast-feeding,

    ask a health-professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • a dults and children over 12 years of age and older:

    apply a thin layer to affected area 6 to 8 hours, not to exceed 3 applications in a 24 hour period.

    • children 12 years or younger: ask a doctor
    • BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
  • Inactive Ingredients

    purified water, eucalyptus, PNC 400 and phenochem.

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    MAMISAN PAIN RELIEVING CREAM LIDOCAINE PLUS MENTHOL 
    lidocaine hydrochloride, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72816-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS GUM (UNII: 72T9EZC2VX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72816-001-0176.6 g in 1 BOTTLE; Type 0: Not a Combination Product06/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/19/2023
    Labeler - PLANTIMEX DISTRIBUTORS INC (185464463)